[The analytic quality in laboratory medicine: problems and perspectives (a lecture)].

The article considers the structure of analytical errors in clinical diagnostic laboratory analysis from the position of GOST R ISO 15189-2009 "Laboratories of medicine. Particular requirements to quality and competence". The key value of metrologic traceability of analyses is emphasized. The role of official standard patterns, control materials and statistical methods applied in quality analysis are discussed. The international experience and applied methodical procedures to implement requirements of ISO 15189 concerning validation and verification of analytical quality are presented. The approaches of protocols E3 23-A, ER 15-A2, N59-A in the sphere of USA laboratory medicine developed by the institute of clinical and laboratory standards are demonstrated. The review of referent patterns and methods is given. The problem of optimization of requirements to quality of production for laboratory diagnostic is discussed. The expedience of organization of the National institute of laboratory standards is substantiated.

[The metrological support of medical laboratory activity].

The article discusses the methodological approaches in implementing of regulations of the Federal law FZ-102 "On the support of unity of measurements in the area of laboratory medicine "from the positions of GOSTK ISO 9001-2008 "The systems of quality management. Requirements" and GOST K ISO 15189-2009 "medical laboratories. The particular requirements to quality and competence". The application of GOSTK ISO 18113.1-5 "The medicine items for diagnostic in vitro. Information provided by manufacturer (marking)" neatly assigns the responsibility for support of metrological correctness of laboratory measurements.

[The practice of development and implementation of quality management systems in medical laboratories. The GOST R ISO 15189-2009 "medical laboratories. The detailed requirements to quality and competence". Particular difficulties of global nature].

The article discusses the methodological issues related to the implementation of international principles of standardization in the format of GOST R ISO 9001-2008 "Quality management systems. Requirements", GOST R ISO 15189-2009 "Medical laboratories. The detailed requirements to quality and competence" and GOST R ISO 18113.1-5 "Medical items for diagnostics in vitro. Information provided by manufacturer (marking)". This approach legibly assigns the responsibility concerning the support of metrological correctness of laboratory measurements. The lacking of both full-value public and sectorial normative documentation and coordinated positions of Rosstandard and Minzdrav of Russia on functioning of medical laboratories is noted.

[Introduction of quality systems into laboratory medicine: methodological aspects].

The paper considers the problems of introducing the quality management systems (QMS) according to GOST R ISO 9001-2001 in the health care facilities of different forms of property and departmental subordination. It gives examples of successfully putting QMS into practice in the companies that manufacture products for laboratory diagnosis in accordance with the Russian and international standardization principles. Methods are presented for training the staff of the facilities in the QMS principles and making a dialogue between laboratories and customers.